MAUDE Adverse Event Report: COLOPLAST A/S (2BO)TITAN OTR SCROT ZERO ANG; INFLATABLE PENILE PROSTHESIS

Model Number ESR9182400

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problem Scarring (2061)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, pump removed due to improper placement/scared in and tubing too short.Touch pump placed in new position for better placement.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the evaluation.The device was not received for evaluation.As examination of the device may not conclusively confirm or disprove the report of improper placement, quality accepts the physician's observations as to the reason for surgical intervention.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• Brand Name: (2BO)TITAN OTR SCROT ZERO ANG
• Type of Device: INFLATABLE PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8351402
• MDR Text Key: 136529524
• Report Number: 2125050-2019-00105
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 05708932487665
• UDI-Public: 05708932487665
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESR9182400
• Device Catalogue Number: ESR918
• Device Lot Number: 3680522
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR